IDN/125/Rev.1
WTO/TBT
ID Indonesien
  • 11 - Medizintechnik
  • 67 - Lebensmitteltechnologie
  • 71 - Chemische Verfahrenstechnik
2020-02-15
2019-12-17

Medicines, Traditional Medicines, Health Supplements, Cosmetics, and Processed Food

Regulation of National Agency of Drug and Food Control (NADFC) Republic of Indonesia on 2D Barcode Application in Drug and Food Control (33 page(s), in Indonesian)

A. 2D Barcode implementation using two methods, consist of:

  1. Authentication: method to tracing and verify legality, batch number, expiration date, and food and drug serial number   2. Identification: method to verify food and drug legality based on marketing authorization

B. Product Implementation:

  1.  Authentication: prescription drugs, biological drugs, narcotics, psychotropic, OTC, Limited OTC with special concern, and processed food including special dietary food.    2.  Identification: medicine including OTC, Limited OTC, traditional medicines, health supplements, cosmetic and processed food.

C. Information in 2D Barcode:

  1. 2D Barcodes authentication contain information including:       a. Marketing authorization number and or product identity number that valid internationally;       b. batch number / production code;       c. expired date;       d. serialization number.

  2. 2D Barcode Identification contain information including:       a. Marketing authorization number       b. Expiration of marketing authorization number

D. Information obtained from the results of the scan using BPOM Mobile application

  1. Product Name   2.  Marketing Authorization Number   3. Expiration of marketing authorization number   4. Name and address of manufacture   5. Packaging

E. Application time on food and drug product implemented in stages (phasing is carried out according to the readiness of the facilities and infrastructure of each industry):

  1. 2D Barcode Authentication     a. Pharmaceutical Industry holder of marketing authorization number are required to apply 2D Barcode in the form of Authentication no later than 2 (two) years starting from issuance of electronic marketing authorization.     b. Pharmaceutical Industry holder of marketing authorization number are required to apply 2D Barcode in the form of Authentication no later than 7 (seven) years after this regulation enacted.

  2. 2D Barcode Identification     a. Pharmaceutical Industry, Traditional Medicine Industry, Health Supplement Industry, Cosmetic Industry, or Food Industry holder of marketing authorization number are required to apply 2D Barcode in the form of Identification no later than 6 (six) months starting from issuance of electronic marketing authorization.     b. Holder of marketing authorization for nonprescription drugs, prescription drugs, traditional medicine, health supplement, cosmetic and processed food are required to apply 2D Barcode in the form of Identification no later than 5 (five) years after this regulation enacted.

This Regulation specifically regulates graphical representation of digital data in a two-dimensional format with high decoding capacity that can be read by optical devices used for identification, track and trace.

The application of 2D Barcodes as regulated in this Regulation includes Medicines, Traditional Medicines, Health Supplements, Cosmetic and Processed Foods which are produced domestically and / or imported into Indonesian territory for trading. The implementation of digital drug and processed food control systems is carried out by providing product packaging authentication technology in the form of 2D Barcode. Product authentication technology is an identity to guarantee the validity of the product so that it is traceable. The flow of digital-based drug and food processing supervision system refers to the 2D Barcode Technical Guidelines listed in the Annex which are an integral part of this Regulation. In addition to the information, 2D Barcodes can also contain other information in the form of serialization numbers and other product identities.